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MARS MRI in Revision THA With a Ceramic Femoral Head and Titanium Sleeve

C

Colorado Joint Replacement

Status

Enrolling

Conditions

Arthroplasty, Replacement, Hip

Treatments

Diagnostic Test: MARS MRI
Diagnostic Test: Cobalt Labs
Diagnostic Test: Titanium Labs
Diagnostic Test: Chromium Labs

Study type

Observational

Funder types

Other

Identifiers

NCT05686915
1969400

Details and patient eligibility

About

Revision total hip replacement using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in individuals doing well after a revision total hip replacement and ceramic bearing surface that utilizes a titanium sleeve.

Full description

Metal-on-metal total hip arthroplasty (THA) were heralded as a solution for two of the most common problems in hip arthroplasty in the last decade, instability and osteolysis. Unfortunately, their failures have led to diminished enthusiasm for this bearing surface. Adverse local tissue reactions (ATLRs) have been well documented as a means of pain and failure in this population. A recent report revealed that the most commonly used bearing surface in total hip arthroplasty, metal-on-polyethylene, may have up to a 28% incidence of MRI abnormalities in asymptomatic hips. Revision THA using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in asymptomatic individuals after a revision THA and ceramic bearing surface that utilizes a titanium sleeve. To our knowledge, this has not been studied previously and may provide important baseline features of this diagnostic tool with this particular bearing surface. We hypothesize that there will be fluid collections in a small but clinically significant portion of asymptomatic patients.

Enrollment

55 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
  • Patient whose age ranges from 18-99
  • Patients who are not experiencing groin pain, thigh pain, or pain with ROM of the hip
  • Patients who are at least 2 years after a revision THA
  • Acetabular implant (cup) was placed in the appropriate position
  • Patients with a Harris Hip Score of >90

Exclusion criteria

  • Patients who do not meet the above criteria
  • Patients unable to have an MRI (i.e. pacemaker, metal implants or issues with claustrophobia requiring sedation)

Trial design

55 participants in 1 patient group

Revision Total Hip Arthroplasty
Description:
Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
Treatment:
Diagnostic Test: MARS MRI
Diagnostic Test: Cobalt Labs
Diagnostic Test: Chromium Labs
Diagnostic Test: Titanium Labs

Trial contacts and locations

1

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Central trial contact

Roseann M Johnson, BS, CCRP

Data sourced from clinicaltrials.gov

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